Study information

Scientific title

Acronym

TBS

Study hypothesis

Twins complicate approximately 2 - 3% of all births. Twin fetuses that are greater than 2500 g at birth are at higher risk of death and neonatal morbidity than singletons of the same birth weight. In addition, the second twin is at higher risk of death and/or serious neonatal morbidity compared with twin A if delivery is vaginal but not if delivery is by caesarean section (CS). There has been one randomised controlled trial (RCT) of planned CS versus planned vaginal birth (VB) for twins: the sample size was too small to answer the question of the better approach to delivery. A Cochrane review has recommended that a larger RCT be undertaken.

As of 04/03/2009 this record has been updated to include an extra country of recruitment: Serbia. All other changes can be found under the relevant fields with the above update date.

Trial setting

Trial type

Patient information sheet

Condition

Twin pregnancies where the first twin is presenting in the cephalic position.

Intervention

Women will be randomised to either a planned vaginal birth group or to a planned caesarean section group.

Randomisation will be carried out at 32 weeks, allowing for planning of the delivery and birth. Eligible consenting women presenting in labour or with an indication for urgent delivery may also be randomised at 32 - 38 weeks.

Timing and Method of Delivery: Because there is an increase in stillbirth rate after 38 weeks gestation, trial participants will be delivered by the planned method of delivery at 38 weeks. Vaginal delivery will be conducted by experienced personnel: if twin B is non-vertex the initial options for delivery are: 1. Spontaneous or assisted vaginal breech delivery (if breech)2. Total breech extraction with or without internal podalic version3. External cephalic version and vaginal delivery of the fetus as a vertex